BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK TIP SYRINGE

    MDR report key: 12439333 · Received September 8, 2021

    Report

    Report Number
    1213809-2021-00620
    Event Type
    Malfunction
    Date Received
    September 8, 2021
    Date of Event
    August 10, 2021
    Report Date
    September 9, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THREE PHOTOS WERE RECEIVED AND EVALUATED. THE PHOTOS SHOWED A SINGLE LOOSE 1ML LL SYRINGE WITH CUSTOMER¿S LABEL ATTACHED A TOP AN EYLEA KIT. THE SCALE WAS OBSERVED TO NOT BE PRINTED CORRECTLY ON THE BARREL WITH A HIGH ZERO LINE CONDITION. ONE FLANGE OF THE BARREL WAS OBSERVED TO BENT UP AND ONE FLANGE WAS BENT DOWN. POTENTIAL ROOT CAUSE FOR THE IMPROPERLY PRINTED SCALE DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. IT IS POSSIBLE THAT THE BENT FLANGE LED TO A MISALIGNMENT OF THE BARREL IN THE MARKER RESULTING IN THE MISPRINTED SCALE OBSERVED. A BENT FLANGE DETECTOR AT THE MARKER WAS INSTALLED END OF JUN 2020, AFTER THIS BATCH WAS MANUFACTURED. NO FURTHER ACTIONS ARE REQUIRED. NO ADDITIONAL ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9051805 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FLANGES ON THE BD LUER-LOK¿ TIP SYRINGE WERE BENT AND DAMAGED, AND THE SCALE MARKINGS WERE OFF "BY A CENTIMETER OR SO". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THEY SAID THE SCALE MARKING APPEARED TO BE SHIFTED AND ¿BENT¿ FLANGES. THE OBSERVATION APPEARS TO HAVE BEEN MADE AT POINT OF USE." "THE REPORTER STATED THE BARREL FLANGE OR FINGER FLANGE GOT OVERHEATED AND WAS BENT. THE SYRINGE WAS FULLY INTACT BUT SEEMS LIKE DURING THE MAKING OF THE SYRINGE, IT GOT BENT. FOR THE SAME SYRINGE, THE VOLUME MARKINGS ON THE END OF THE SYRINGE IS INCORRECT. THE MARKINGS WERE OFF BY A CENTIMETER OR SO. THEREFORE, THE AMOUNT OF MEDICATION DELIVERED WOULD BE INCORRECT. THE EYLEA VIAL WAS USED BUT ANOTHER BD SYRINGE WAS USED INSTEAD."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE CUSTOMER'S ADDRESS IS UNKNOWN. UNKNOWN, NEW JERSEY, 00000 USA HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FLANGES ON THE BD LUER-LOK¿ TIP SYRINGE WERE BENT AND DAMAGED, AND THE SCALE MARKINGS WERE OFF "BY A CENTIMETER OR SO". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THEY SAID THE SCALE MARKING APPEARED TO BE SHIFTED AND ¿BENT¿ FLANGES. THE OBSERVATION APPEARS TO HAVE BEEN MADE AT POINT OF USE." "THE REPORTER STATED THE BARREL FLANGE OR FINGER FLANGE GOT OVERHEATED AND WAS BENT. THE SYRINGE WAS FULLY INTACT BUT SEEMS LIKE DURING THE MAKING OF THE SYRINGE, IT GOT BENT. FOR THE SAME SYRINGE, THE VOLUME MARKINGS ON THE END OF THE SYRINGE IS INCORRECT. THE MARKINGS WERE OFF BY A CENTIMETER OR SO. THEREFORE, THE AMOUNT OF MEDICATION DELIVERED WOULD BE INCORRECT. THE EYLEA VIAL WAS USED BUT ANOTHER BD SYRINGE WAS USED INSTEAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1339387 BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309628 9051805 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1